Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

How much? Pfiz­er ex­pects to reap at least $26B from Covid vac­cine in 2021

Pfiz­er’s Covid-19 vac­cine is like­ly to bring in about $26 bil­lion in 2021 rev­enues, which is more than $10 bil­lion more than the bio­phar­ma be­he­moth pre­vi­ous­ly pre­dict­ed, the com­pa­ny an­nounced Tues­day morn­ing.

The com­pa­ny said that fig­ure is based on signed con­tracts as of mid-April that amount to 1.6 bil­lion dos­es of the vac­cine to be de­liv­ered this year. And the dra­mat­ic uptick in guid­ance is due to ad­di­tion­al sup­ply agree­ments that have been signed since the com­pa­ny’s pre­vi­ous guid­ance. More may be com­ing too.

“We al­so are in on­go­ing dis­cus­sions with mul­ti­ple coun­tries around the world about their needs, and we ex­pect these dis­cus­sions to lead to ad­di­tion­al sup­ply agree­ments,” Pfiz­er CEO Al­bert Bourla said in pre­pared re­marks on Tues­day’s con­fer­ence call.

To put in­to per­spec­tive how much $26 bil­lion is for Pfiz­er: It’s more than any oth­er drug or vac­cine has earned in a year, ever. And it’s al­most 30% of what the com­pa­ny ex­pects in to­tal rev­enues for 2021, and it’s more than dou­ble what the com­pa­ny ex­pects to spend on R&D (about $10 bil­lion in 2021).

“Fac­tor­ing in the costs to man­u­fac­ture, mar­ket and dis­trib­ute BNT162b2 [the vac­cine], in­clud­ing ap­plic­a­ble roy­al­ty ex­pens­es and a 50% gross prof­it split with BioN­Tech, as well as shared R&D ex­pens­es re­lat­ed to BNT162b2 and costs as­so­ci­at­ed with oth­er as­sets cur­rent­ly in de­vel­op­ment for the pre­ven­tion and treat­ment of COVID-19, the rev­enue im­pact on the bot­tom line of our fi­nan­cials is an­tic­i­pat­ed to be in the high 20s as a per­cent­age of rev­enue,” a Pfiz­er spokesper­son said.

As of May 3, Pfiz­er and its part­ner BioN­Tech have shipped about 430 mil­lion dos­es of their vac­cine to 91 coun­tries and ter­ri­to­ries around the world, the com­pa­nies said. Al­ready in the first quar­ter of 2021, Pfiz­er said its vac­cine con­tributed $3.5 bil­lion in glob­al rev­enues, which com­pares with $154 mil­lion in sales in the fourth quar­ter of 2020 (the vac­cine won emer­gency use au­tho­riza­tion from the FDA in De­cem­ber).

Bourla al­so not­ed that the com­pa­ny ex­pects to sub­mit an ap­pli­ca­tion to the FDA for a full ap­proval of the vac­cine this month.

Be­yond 2021, the com­pa­ny said it’s al­ready held ne­go­ti­a­tions with Cana­da to sup­ply up to 125 mil­lion dos­es in 2022 and 2023, with op­tions to pur­chase up to 60 mil­lion ad­di­tion­al dos­es in 2024, and with Is­rael to sup­ply mil­lions of dos­es in 2022 and be­yond. Talks with oth­er coun­tries are on­go­ing too and Pfiz­er notes that it us­es three pric­ing tiers for gov­ern­ment con­tracts de­pend­ing on the rel­a­tive wealth of na­tions.

Those ad­di­tion­al dos­es will re­quire ad­di­tion­al man­u­fac­tur­ing ca­pac­i­ty, which the com­pa­ny ex­pects to have as it’s plan­ning for ca­pac­i­ty to man­u­fac­ture at least 3 bil­lion dos­es of the vac­cine in 2022, which com­pares with 2.5 bil­lion dos­es this year.

Use of the vac­cine is ex­pect­ed to soon ex­pand in the US for ado­les­cents aged 12 to 15, and the com­pa­ny ex­pects to have de­fin­i­tive read­outs and sub­mit for an EUA for two oth­er groups of chil­dren aged 2 to 5 years and 5 to 11 years, both in Sep­tem­ber, Bourla not­ed.

Pfiz­er is al­so work­ing on tri­als to test the vac­cine against vari­ants.

Bourla said the com­pa­ny is eval­u­at­ing the safe­ty and im­muno­genic­i­ty of a third dose of the ex­ist­ing for­mu­la­tion of its vac­cine “to un­der­stand the ef­fect of a boost­er on im­mu­ni­ty against the SARS-CoV-2 vari­ants in cir­cu­la­tion. Ad­di­tion­al­ly, we have start­ed an eval­u­a­tion of an up­dat­ed, pro­to­type vari­ant ver­sion of our vac­cine that en­codes the spike pro­tein of the lin­eage B.1.351 SARS-CoV-2 vari­ant, which in­cludes the mu­ta­tion E484K, first iden­ti­fied in South Africa.

“This study is de­signed to es­tab­lish a reg­u­la­to­ry path­way to up­date the cur­rent vac­cine to ad­dress any fu­ture vari­ant of po­ten­tial con­cern in ap­prox­i­mate­ly 100 days, if need­ed. We ex­pect to have im­muno­genic­i­ty da­ta for both stud­ies in ear­ly Ju­ly,” he added.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

In­cyte keeps rolling on top­i­cal cream for JAK in­hibitor, pass­ing two PhI­II tests in vi­tili­go

As Incyte prepares to potentially hit the market with a topical formulation of its cash cow ruxolitinib in atopic dermatitis, the Wilmington, DE-based company is beefing up its data package for another indication: vitiligo.

Incyte released Phase III results from two of its clinical vitiligo programs Monday morning, saying both studies met their primary endpoints of patients achieving at least 75% improvement from baseline in repigmentation of the face. The data will likely lead Incyte to ask for approval in both the US and Europe for those older than 12 before the end of the year.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients — but can the CEO win over skep­tics?

While Cytokinetics’ heart drug technically met its primary endpoint back in November, it missed a key secondary endpoint — reduction in cardiovascular death — which eventually cost the company two partnerships. Now the team is back with data suggesting the drug works better in sicker patients, and it’s planning a trip to the FDA.

In a post-hoc analysis, which can be a very difficult sale at the FDA, Cytokinetics separated patients from the Phase III GALACTIC-HF study into four quartiles based on ejection fraction, a measurement of how well the left ventricle pumps blood with each heartbeat. Patients in the lower two quartiles — those with an EF of 22% or lower, and between 29% to 32% — saw a 15% and 17% relative risk reduction of heart failure events and cardiovascular death combined, Cytokinetics reported at ACC. No difference was seen in the upper two quartiles.

Neil Desai, Aadi Bioscience CEO (Specialised Therapeutics via YouTube)

Patrick Soon-Sh­iong's for­mer chief sci­en­tist takes can­cer com­pa­ny pub­lic in $155M re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

SPACs have become the preferred fast track for public markets over the past year, but apparently there’s still room for a good, old-fashioned reverse merger.

Cancer-focused Aadi Bioscience announced Monday that they would merge with the struggling public biotech Aerpio Pharmaceuticals. To go along with the merger, Aadi raised $155 million from private investors to commercialize their lead drug, Fyarro, which is now sitting before the FDA. Acuta Capital Partners and KVP Capital led the round.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.